The Budesonide in Babies (BiB) Study

The Budesonide in Babies (BiB) study is investigating if adding a steroid treatment to our breathing support can prevent chronic lung disease (bronchopulmonary dysplasia) and increase the survival rates in very premature babies. Bronchopulmonary dysplasia (BPD) is a chronic inflammatory lung disease that is often the result of underdeveloped lungs. Many infants require breathing support shortly after birth to help oxygenate the lungs as well as keep them open. Surfactant is an important medication we give our babies to prevent the lungs from collapsing.

Babies with BPD have fragile lungs that can be easily irritated or inflamed. In this study, we provide a steroid (Budesonide) to reduce and prevent BPD. Our aim is to assess whether giving Budesonide with surfactant reduces BPD better than surfactant alone.

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Purpose & Aim

Population of the study: Extremely preterm infants <29 weeks gestation; or ≤1000 grams (about 2lbs 3oz) birthweight
Intervention: Surfactant + Budesonide
Control (Usual care in our hospital): Surfactant only
Outcome: Reduce BPD or death by 36 weeks PMA

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Trial Information

Target Enrollment: 1160
Funder: NIH NICHD Neonatal Research Network (NRN)
Duration of Study: April 2021 – September 2027

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Study Principal Investigator

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Links

ClinicalTrials.gov